Modelled impact of virtual fractional flow reserve in patients undergoing coronary angiography (VIRTU-4).

BACKGROUND: The practical application of 'virtual' (computed) fractional flow reserve (vFFR) based on invasive coronary angiogram (ICA) images is unknown. The objective of this cohort study was to investigate the potential of vFFR to guide the management of unselected patients undergoing ICA. The hypothesis was that it changes management in >10% of cases. METHODS: vFFR was computed using the Sheffield VIRTUheart system, at five hospitals in the North of England, on 'all-comers' undergoing ICA for non-ST-elevation myocardial infarction acute coronary syndrome (ACS) and chronic coronary syndrome (CCS). The cardiologists' management plan (optimal medical therapy, percutaneous coronary intervention (PCI), coronary artery bypass surgery or 'more information required') and confidence level were recorded after ICA, and again after vFFR disclosure. RESULTS: 517 patients were screened; 320 were recruited: 208 with ACS and 112 with CCS. The median vFFR was 0.82 (0.70-0.91). vFFR disclosure did not change the mean number of significantly stenosed vessels per patient (1.16 (±0.96) visually and 1.18 (±0.92) with vFFR (p=0.79)). A change in intended management following vFFR disclosure occurred in 22% of all patients; in the ACS cohort, there was a 62% increase in the number planned for medical management, and in the CCS cohort, there was a 31% increase in the number planned for PCI. In all patients, vFFR disclosure increased physician confidence from 8 of 10 (7.33-9) to 9 of 10 (8-10) (p<0.001). CONCLUSION: The addition of vFFR to ICA changed intended management strategy in 22% of patients, provided a detailed and specific 'all-in-one' anatomical and physiological assessment of coronary artery disease, and was accompanied by augmentation of the operator's confidence in the treatment strategy.

Characterisation of the octogenarians presenting to the diagnostic heart failure clinic: SHEAF registry.

INTRODUCTION: Heart failure (HF) incidence is increasing in older adults with high hospitalisation and mortality rates. Treatment is complicated by side effects and comorbidities. We investigated the clinical characteristics of octogenarians presenting to the HF clinic. METHODS: Data were collected on octogenarians (80-89 years) referred to the HF clinic in two periods. The data included demographics, HF phenotype, comorbidities, symptoms and treatment. We investigate the temporal changes in clinical characteristics using χ2 test. We aimed to determine the clinical characteristics which were associated with optimisation of HF pharmacological intervention in the clinic, conducting multivariate regression analysis. Statistical significance is determined at p<0.05. RESULTS: Data were collected in April 2012 to January 2014 and in June 2021 to December 2022. In this cross-sectional study of temporal data, 571 octogenarians were referred to the clinic in the latter period, in whom the prevalence of HF was 68.48% (391 patients). HF with preserved ejection fraction (HFpEF) was the most common phenotype and increased significantly compared with the first period (46.3% and 29.2%, p<0.001). Frailty, chronic kidney disease and ischaemic heart disease increased significantly versus the first period (p<0.001). During the second period, and following the consultation, of the patients with HF with reduced ejection fraction (HFrEF), 86.4% and 82.7% were on a beta blocker and on an ACE inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, respectively. Clinical characteristics associated with further optimisations of HF pharmacological therapy in the HF clinic were: New York Heart Association (NYHA) functional class III and the presence of HFrEF phenotype CONCLUSIONS: With a prevalence of HF at 68% among the octogenarians referred to the HF clinic, HFpEF incidence is rising. The decision to optimise HF pharmacological treatment in octogenarians is driven by NYHA functional class III and the presence of HFrEF phenotype.

Anatomical characterization of pulmonary artery and implications to pulmonary artery pressure monitor implantation.

In patients with heart failure, guideline directed medical therapy improves outcomes and requires close patient monitoring. Pulmonary artery pressure monitors permit remote assessment of cardiopulmonary haemodynamics and facilitate early intervention that has been shown to decrease heart failure hospitalization. Pressure sensors implanted in the pulmonary vasculature are stabilized through passive or active interaction with the anatomy and communicate with an external reader to relay invasively measured pressure by radiofrequency. A body mass index > 35 kg/m2 and chest circumference > 165 cm prevent use due to poor communication. Pulmonary vasculature anatomy is variable between patients and the pulmonary artery size, angulation of vessels and depth of sensor location from the chest wall in heart failure patients who may be candidates for pressure sensors remains largely unexamined. The present study analyses the size, angulation, and depth of the pulmonary artery at the position of implantation of two pulmonary artery pressure sensors: the CardioMEMS sensor typically implanted in the left pulmonary artery and the Cordella sensor implanted in the right pulmonary artery. Thirty-four computed tomography pulmonary angiograms from patients with heart failure were analysed using the MIMICS software. Distance from the bifurcation of the pulmonary artery to the implant site was shorter for the right pulmonary artery (4.55 ± 0.64 cm vs. 7.4 ± 1.3 cm) and vessel diameter at the implant site was larger (17.15 ± 2.87 mm vs. 11.83 ± 2.30 mm). Link distance (length of the communication path between sensor and reader) was shorter for the left pulmonary artery (9.40 ± 1.43 mm vs. 12.54 ± 1.37 mm). Therefore, the detailed analysis of pulmonary arterial anatomy using computed tomography pulmonary angiograms may alter the choice of implant location to reduce the risk of sensor migration and improve readability by minimizing sensor-to-reader link distance.

Cardiovascular medication in patients with raised NT-proBNP, but no heart failure in the SHEAF registry.

OBJECTIVES: We aim to assess the association of cardiovascular medications with outcomes of patients referred to the diagnostic heart failure (HF) clinic with symptoms or signs of possible HF, raised N-terminal pro-brain-type natriuretic peptide (NT-proBNP) but no evidence of HF on transthoracic echocardiography (TTE). METHODS: Data were collected prospectively into the Sheffield HEArt Failure (SHEAF) registry between April 2012 and January 2020. The inclusion criteria were symptoms or signs suggestive of HF, NT-proBNP >400 pg/mL, but no evidence of HF on TTE. Cox proportional-hazards regression model was used to investigate the association between the survival time of patients and different cardiovascular medications. The outcome was defined as all-cause mortality. RESULTS: From the SHEAF registry, we identified 1766 patients with raised NT-proBNP with no evidence of HF on TTE. Survival was higher among the younger patients, and among those with hypertension or atrial fibrillation (AF). Mortality was increased with male gender, valvular heart disease and chronic kidney disease. Using univariate Cox proportional-hazards regression, the only cardiac therapeutic agent independently associated with all-cause mortality was beta-blocker (HR 0.86; 95% CI: 0.77 to 0.97; p=0.02). The use of beta-blockers was significantly higher in patients with AF (63% vs 39%, p<0.01) and hypertension (51% vs 42%, p<0.01). However, using multivariate Cox proportional-hazards regression to adjust for all variables associated with mortality, the influence of beta-blockers became non-significant (HR 0.96; 95% CI: 0.85 to 1.1, p=0.49). CONCLUSION: When all variables associated with mortality are considered, none of the cardiovascular agents are associated with the improved survival of patients with suspected HF, raised NT-proBNP but no HF on echocardiography.

Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block.

AIMS: To determine whether triventricular (TriV) pacing is feasible and improves CRT response compared to conventional biventricular (BiV) pacing in patients with left bundle branch block (LBBB) and intermediate QRS prolongation (120-150 ms). METHODS AND RESULTS: Between October 2015 and November 2019, 99 patients were recruited from 11 UK centres. Ninety-five patients were randomized 1:1 to receive TriV or BiV pacing systems. The primary endpoint was feasibility of TriV pacing. Secondary endpoints assessed symptomatic and remodelling response to CRT. Baseline characteristics were balanced between groups. In the TriV group, 43/46 (93.5%) patients underwent successful implantation vs. 47/49 (95.9%) in the BiV group. Feasibility of maintaining CRT at 6 months was similar in the TriV vs. BiV group (90.0% vs. 97.7%, P = 0.191). All-cause mortality was similar between TriV vs. BiV groups (4.3% vs. 8.2%, P = 0.678). There were no significant differences in echocardiographic LV volumes or clinical composite scores from baseline to 6-month follow-up between groups. CONCLUSION: Implantation of two LV leads to deliver and maintain TriV pacing at 6 months is feasible without significant complications in the majority of patients. There was no evidence that TriV pacing improves CRT response or provides additional clinical benefit to patients with LBBB and intermediate QRS prolongation and cannot be recommended in this patient group. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT02529410.

Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study.

AIMS: The CardioMEMS HF System Post-Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic-guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia. METHODS AND RESULTS: COAST is a prospective, international, multicentre, open-label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic-guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system-related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72-88%] than the previous 12 months (0.27 vs. 1.52 events/patient-year, respectively, P < 0.0001). Freedom from device/system-related complications and pressure sensor failure at 2 years was 100% and 99%, respectively. CONCLUSIONS: Remote haemodynamic-guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic-guided HF management was safe and significantly reduced hospitalization in a group of high-risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF. Clinical registration number: ClinicalTrials.gov identifier: NCT02954341.

Characterisation of the patients with suspected heart failure: experience from the SHEAF registry.

OBJECTIVES: To characterise and risk-stratify patients presenting to a heart failure (HF) clinic according to the National Institute for health and Care Excellence (NICE) algorithm. METHODS: This is an observational study of prospectively collected data in the Sheffield HEArt Failure registry of consecutive patients with suspected HF between April 2012 and January 2020. Outcome was defined as all-cause mortality. RESULTS: 6144 patients were enrolled: 71% had HF and 29% had no HF. Patients with N-terminal pro-brain-type natriuretic peptide (NT-proBNP) >2000 pg/mL were more likely to have HF than those with NT-proBNP of 400-2000 pg/mL (92% vs 64%, respectively). Frequency of HF phenotypes include: HF with preserved ejection fraction (HFpEF) (33%), HF with reduced ejection fraction (HFrEF) (29%), HF due to valvular heart disease (4%), HF due to pulmonary hypertension (5%) and HF due to right ventricular systolic dysfunction (1%). There were 1485 (24%) deaths over a maximum follow-up of 6 years. The death rate was higher in HF versus no HF (11.49 vs 7.29 per 100 patient-years follow-up, p<0.0001). Patients with HF and an NT-proBNP >2000 pg/mL had lower survival than those with NT-proBNP 400-2000 pg/mL (3.8 years vs 5 years, p<0.0001). Propensity matched survival curves were comparable between HFpEF and HFrEF (p=0.88). CONCLUSION: Our findings support the use by NICE's HF diagnostic algorithm of tiered triage of patients with suspected HF based on their NT-proBNP levels. The two pathways yielded distinctive groups of patients with varied diagnoses and prognosis. HFpEF is the most frequent diagnosis, with its challenges of poor prognosis and paucity of therapeutic options.

Clinical predictors of all-cause mortality in patients presenting to specialist heart failure clinic with raised NT-proBNP and no heart failure.

AIMS: Clinical outcomes for patients suspected of having heart failure (HF) who do not meet the diagnostic criteria of any type of HF by echocardiography remain unknown. The aim of this study was to investigate the clinical predictors of all-cause mortality in patients with suspected HF, a raised N-terminal pro-b-type natriuretic peptide (NTproBNP) and who do not meet the diagnostic criteria of any type of HF by echocardiography. METHODS AND RESULTS: Relevant data were taken from the Sheffield HEArt Failure (SHEAF) registry (222349P4). The inclusion criteria were presence of symptoms raising suspicion of HF, NTproBNP > 400 pg/mL, and preserved left ventricular function. Exclusion criteria were any type of HF by echocardiography. The outcome was defined as all-cause mortality. Cox proportional-hazards regression model was used to investigate the association between the survival time of patients and clinical variables; 1031 patients were identified with NTproBNP > 400 pg/mL but who did not have echocardiographic evidence of HF. All-cause mortality was 21.5% (222 deaths) over the mean follow-up (FU) period of 6 ± 2 years. NTproBNP was similar in patients who were alive or dead (P = 0.96). However, age (HR 1, P < 0.01), chronic kidney disease (CKD, HR 1.2, P < 0.01), chronic pulmonary obstructive disease (COPD, HR 1.6, P < 0.01), dementia (HR 5.9, P < 0.01), male gender (HR 1.4, P < 0.01), first-degree atrioventricular block (HR 2.1, P < 0.01), left axis deviation (HR 1.6, P = 0.04), and diabetes (HR 1.4, P = 0.03) were associated with all-cause mortality. In multivariate regression, age, gender, CKD stage, COPD, and dementia were independently associated with mortality. In patients with NTproBNP > 627 pg/mL, NYHA class predicted death (II, 19.6%; III, 27.4%; IV, 66.7%; P < 0.01). CONCLUSIONS: Patients with no HF on echocardiography but raised NTproBNP suffer excess mortality particularly in the presence of certain clinical variables. Age, male gender, worsening CKD stage, presence of COPD, and dementia are independently associated with all-cause mortality in these patients. An NTproBNP > 627 pg/mL coupled with NYHA class could identify patients at greatest risk of death.

Multicenter Randomized Controlled Crossover Trial Comparing Hemodynamic Optimization Against Echocardiographic Optimization of AV and VV Delay of Cardiac Resynchronization Therapy: The BRAVO Trial.

OBJECTIVES: BRAVO (British Randomized Controlled Trial of AV and VV Optimization) is a multicenter, randomized, crossover, noninferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular delay with a noninvasive blood pressure method. BACKGROUND: Cardiac resynchronization therapy including AV delay optimization confers clinical benefit, but the optimization requires time and expertise to perform. METHODS: This study randomized patients to echocardiographic optimization or hemodynamic optimization using multiple-replicate beat-by-beat noninvasive blood pressure at baseline; after 6 months, participants were crossed over to the other optimization arm of the trial. The primary outcome was exercise capacity, quantified as peak exercise oxygen uptake. Secondary outcome measures were echocardiographic left ventricular (LV) remodeling, quality-of-life scores, and N-terminal pro-B-type natriuretic peptide. RESULTS: A total of 401 patients were enrolled, the median age was 69 years, 78% of patients were men, and the New York Heart Association functional class was II in 84% and III in 16%. The primary endpoint, peak oxygen uptake, met the criterion for noninferiority (pnoninferiority = 0.0001), with no significant difference between the hemodynamically optimized arm and echocardiographically optimized arm of the trial (mean difference 0.1 ml/kg/min). Secondary endpoints for noninferiority were also met for symptoms (mean difference in Minnesota score 1; pnoninferiority = 0.002) and hormonal changes (mean change in N-terminal pro-B-type natriuretic peptide -10 pg/ml; pnoninferiority = 0.002). There was no significant difference in LV size (mean change in LV systolic dimension 1 mm; pnoninferiority < 0.001; LV diastolic dimension 0 mm; pnoninferiority <0.001). In 30% of patients the AV delay identified as optimal was more than 20 ms from the nominal setting of 120 ms. CONCLUSIONS: Optimization of cardiac resynchronization therapy devices by using noninvasive blood pressure is noninferior to echocardiographic optimization. Therefore, noninvasive hemodynamic optimization is an acceptable alternative that has the potential to be automated and thus more easily implemented. (British Randomized Controlled Trial of AV and VV Optimization [BRAVO]; NCT01258829).

Dual-site right ventricular pacing in patients undergoing cardiac resynchronization therapy: Results of a multicenter propensity-matched analysis.

BACKGROUND: Dual-site right ventricular pacing (Dual RV) has been proposed as an alternative for patients with heart failure undergoing cardiac resynchronization therapy (CRT) with a failure to deliver a coronary sinus (CS) lead. Only short-term hemodynamic and echocardiographic results of Dual RV are available. We aimed to assess the long-term results of Dual RV and its impact on survival. METHODS: Multicenter retrospective assessment of all CRT implants during a 12-year period. Patients with failed CS lead implantation, treated with Dual RV, were followed and assessed for the primary endpoint of all-cause mortality and/or heart transplant. A control group was obtained from contemporary patients using propensity matching for all available baseline variables. RESULTS: Ninety-three patients were implanted with Dual RV devices and compared with 93 matched controls. During a median of 1,273 days (interquartile range 557-2,218), intention-to-treat analysis showed that all-cause mortality and/or heart transplant was higher in the Dual RV group (adjusted hazard ratio [HR] = 1.66, 95% confidence interval [CI] 1.12-2.47, P = 0.012). As-treated analysis yielded similar results (HR = 1.97, 95% CI 1.31-2.96, P = 0.001). Cardiac device-related infections occurred seven times more frequently in the Dual RV site group (HR = 7.60, 95% CI 1.51-38.33, P = 0.014). Among Dual RV nonresponders, four had their apical leads switched off, five required an epicardial LV lead insertion, a transseptal LV lead was implanted in two, and in nine patients, after reviewing the CS venogram, a new CS lead insertion was successfully attempted. CONCLUSION: Dual RV pacing is associated with worse clinical outcomes and higher complication rates than conventional CRT.

Ventricular Arrhythmia Burden in Patients With Heart Failure and Cardiac Resynchronization Devices: The Importance of Renal Function.

BACKGROUND: Chronic kidney disease (CKD) is a risk factor for arrhythmias in patients with heart failure (HF). However, the effects of CKD on ventricular arrhythmia (VA) burden in patients with cardiac resynchronization therapy and defibrillator (CRT-D) devices in a primary prevention setting are unknown. OBJECTIVE: To determine whether baseline CKD is associated with increased risk of VA in patients implanted with primary prevention CRT-D devices. METHODS AND RESULTS: In this retrospective study, 199 consecutive primary prevention CRT-D recipients (2005-2010) were stratified by estimated glomerular filtration rate (eGFR) levels prior to device implantation with 106 (53.2%) ≥CKD III (eGFR < 60 mL/min/1.73 m2 ) (CKD group). CKD group patients were significantly older (70.0 ± 10 years vs. 61.3 ± 12 years, P < 0.05) with higher prevalence of ischemic cardiomyopathy (56.2% vs. 40.2%, P < 0.05). Detected ventricular tachycardia (VT)/ventricular fibrillation (VF) episodes resulting in device therapy occurred significantly more frequently in the CKD group [40/106(37.8%)] than controls [24/93(25.8%)], (odd ratio [OR] = 1.74, 95% confidence interval [CI] = 1.01-3.2, P = 0.05). At 5-year follow-up, interval censored data analysis showed 41% VT/VF incidence in the CKD group compared to 24% incidence in controls (P < 0.05). Cox proportional hazards model identified CKD > III as the only predictor of sustained VA in this group (adjusted hazard ratio [HR] 2.92, CI = 1.39-6.1, P = 0.004). CONCLUSION: Baseline CKD is a strong independent risk factor for VA in primary prevention CRT-D recipients. Further understanding of the underlying arrhythmogenic mechanisms relating to CKD may be of interest to allow appropriate correction and prevention. Device programming in this cohort may need to reflect this increased risk.

Long-Term Results of Triventricular Versus Biventricular Pacing in Heart Failure: A Propensity-Matched Comparison.

OBJECTIVES: The goal of this study was to assess the impact of triventricular pacing (Tri-V) on long-term survival. BACKGROUND: Biventricular pacing (Bi-V) is an important adjunctive treatment in advanced heart failure, but almost one-third of patients experience no improvement with this therapy and are labeled as nonresponders. Adding a third ventricular lead (Tri-V) has been shown to be feasible and provides favorable acute results when assessed by using echocardiographic, hemodynamic, and clinical endpoints. However, the long-term effects of Tri-V pacing and how it affects long-term survival remains unknown. METHODS: This single-center, propensity score-matched cohort study compared 34 patients with advanced heart failure who underwent implantation with Tri-V devices versus 34 control subjects treated with Bi-V pacing. Clinical outcomes during a median of 2,478 days (IQR: 1,183 to 3,214 days) were compared. RESULTS: Tri-V-treated patients compared with Bi-V-treated patients presented with a trend for shorter battery longevity (time to box change, 1,758 ± 360 days vs. 1,993 ± 408 days; p = 0.072). Incidence of lead dislodgement (Tri-V vs. Bi-V, 0.86 vs. 1.10 per 100 patient-years; p = 0.742), device-related infection (Tri-V vs. Bi-V, 1.83 vs. 1.76 per 100 patient-years; p = 0.996), and refractory phrenic nerve capture (Tri-V vs. Bi-V, 0.48 vs. 1.84 per 100 patient-years; p = 0.341) was comparable in the 2 groups. Episodes of ventricular arrhythmia requiring implantable cardioverter-defibrillator intervention occurred more frequently in the Bi-V group versus the Tri-V group (6.55 vs. 16.88 per 100 patient-years; adjusted hazard ratio: 0.31; 95% confidence interval: 0.14 to 0.66; p = 0.002). Lower all-cause mortality and heart transplant was observed in the Tri-V group compared with the Bi-V group (6.99 vs. 11.92 per 100 patient-years; adjusted hazard ratio: 0.44; 95% confidence interval: 0.23 to 0.85; p = 0.015). CONCLUSIONS: Tri-V displayed a similar safety profile compared with Bi-V and was associated with potential benefits regarding long-term survival and ventricular arrhythmia burden.

A study of implanted cardiac rhythm recorders in advanced cardiac AL amyloidosis.

AIMS: AL amyloidosis may respond to chemotherapy but two-thirds of patients with severe cardiac involvement die within a year of diagnosis, purportedly from tachyarrhythmias or electromechanical dissociation. We sought to characterize the nature of cardiac arrhythmias in severe cardiac AL amyloidosis using implanted cardiac rhythm recorders. METHODS AND RESULTS: Implantable loop recorders (ILRs) were inserted within 24 h of baseline evaluation at the UK National Amyloidosis Centre, into 20 consecutive patients with newly diagnosed severe cardiac AL amyloidosis and symptoms of syncope or pre-syncope. Weekly ILR recordings and additional recordings at the time of symptoms were obtained. Median (range) follow-up from baseline was 308 (10-399) days. Thirteen patients died, and median survival in the whole cohort was 61 days from device insertion. In each of eight evaluable cases, death was heralded by bradycardia, usually associated with complete atrioventricular block (CAVB), followed shortly thereafter by pulseless electrical activity. Four patients received pacemakers, a median (range) of 7 (3-38) h after development of symptomatic CAVB, but these did not prevent rapid cardiac decompensation and death in three cases. Despite 272 loop recordings, there was only one episode of non-sustained ventricular tachycardia, which was preceded by severe bradycardia. Patients who died had significantly worse global left ventricular strain on echocardiography (P = 0.029) and reduced 6 min walk distance (P = 0.048) at baseline compared with survivors. CONCLUSIONS: The discovery that bradyarrhythmias heralded terminal cardiac decompensation in most patients with severe cardiac AL amyloidosis supports a study of prophylactic pacemaker insertion in this patient population.

Is CRT pro-arrhythmic? A comparative analysis of the occurrence of ventricular arrhythmias between patients implanted with CRTs and ICDs.

UNLABELLED: Aim and Hypothesis: Despite the proven symptomatic and mortality benefit of cardiac resynchronization therapy (CRT), there is anecdotal evidence it may be pro-arrhythmic in some patients. We aimed to identify if there were significant differences in the incidence of ventricular arrhythmias (VAs) in patients undergoing CRT-D and implantable cardioverter-defibrillators (ICD) implantation for primary prevention indication. We hypothesized that CRT is unlikely to be pro-arrhythmic based on the positive mortality and morbidity data from large randomized trials. METHODS AND RESULTS: A retrospective analysis of device therapies for VA in a primary prevention device cohort was performed. Patients with ischemic (IHD) and non-ischemic (DCM) cardiomyopathy and ICD or CRT+ICD devices (CRT-D) implanted between 2005 and 2007 without prior history of sustained VA were included for analysis. VA episodes were identified from stored electrograms and defined as sustained (VT/VF) if therapy [anti-tachycardia pacing (ATP) or shocks] was delivered or non-sustained (NSVT) if not. Of a total of 180 patients, 117 (68% male) were in the CRT-D group, 42% IHD, ejection fraction (EF) 24.5 ± 8.2% and mean follow-up 23.9 ± 9.8 months. 63 patients (84% male) were in the ICD group, 60% IHD, EF 27.7 ± 7.2% and mean follow-up 24.6 ± 10.8 months. Overall, there was no significant difference in the incidence of VA (35.0 vs. 38.1%, p = 0.74), sustained VT (21.3 vs. 28.5%, p = 0.36) or NSVT (12.8 vs. 9.5%, p = 0.63) and no significant difference in type of therapy received for VT/VF: ATP (68 vs. 66.6%, p = 0.73) and shocks (32 vs. 33.3%, p = 0.71) between the CRT-D and ICD groups, respectively. CONCLUSION: In patients with cardiomyopathy receiving CRT-D and ICDs for primary prophylaxis, there was no significant difference in the incidence of VA. From this single center retrospective analysis, there is no evidence to support cardiac resynchronization causing pro-arrhythmia.

A simple infection-control protocol to reduce serious cardiac device infections.

AIM: Device infection is a serious complication and is considered procedure-related if occurring within 12 months of an intervention. We analysed the effectiveness of a simple infection-control protocol (ICP) at reducing cardiac device infections (CDIs) in a tertiary referral centre. METHODS AND RESULTS: Prior to the introduction of a new ICP, we retrospectively analysed all simple and complex device implants, related procedures, and infections over a 3-year period. A new protocol was implemented from November 2007, including antibiotic prophylaxis determined by risk stratification, improved glycaemic control, specific skin preparation, and closure techniques, as well as different diathermy settings. Follow-up data for all patients were collected. Risk factors for infection were compared between pre- and post-intervention groups to ensure that the populations were comparable. A cost analysis of CDI and a review of the commonly identified micro-organisms were also undertaken. One thousand seven hundred and ninety-eight procedures were performed between November 2004 and November 2007 and 981 procedures between November 2007 and May 2009. There were no significant differences in the risk factors for infection between the two groups. Following the introduction of the ICP, there was a 54% reduction in the incidence of CDI from 1.3 to 0.6% (P < 0.03; CI 0.25, 1.36). Most patients with CDI had negative blood cultures or grew Staphylococcus sp. The average cost was £30 958.40 per infection incident and the cost of the new ICP was minimal. CONCLUSIONS: A significant reduction in CDI can be achieved with the introduction of a simple ICP with substantial cost savings.

An 8-year single-centre experience of cardiac resynchronisation therapy: procedural success, early and late complications, and left ventricular lead performance.

AIMS: Despite the increasing number of device implants worldwide, little is known about the early and late complications of cardiac resynchronisation therapy (CRT) or the incidence of these complications in patients with different heart failure aetiologies. We aim to determine procedural success and early and late complications in CRT patients. METHODS AND RESULTS: All early (<90 days) and late (>90 days) complications occurring over 490 consecutive CRT procedures in 402 patients, from a large single-centre registry between 2000 and 2009 were analysed. Mean follow-up duration was 1012 ± 610 days. In addition, procedural data and long-term left ventricular (LV) lead performance were examined. The mean age of patients was 65 ± 15 years, 31% were female. The majority of devices (70%) were CRT-defibrillators. Left ventricular lead implantation was achieved after one or more than one attempt in 96.7% of patients (first procedure was successful in 95.1%). The incidence of early and late complications was 9.4% and 6.1% respectively. Infection and lead displacement were the most common complications. Dilated cardiomyopathy (DCM) was associated with significantly more complications than ischaemic cardiomyopathy (P = 0.01) and these occurred later in the DCM population. Long-term LV lead performance was comparable with that of right atrial and ventricular leads. CONCLUSION: Transvenous implantation of the LV lead is safe and achievable for CRT with high procedural success rates. For the first time we describe the late complications from CRT in different heart failure populations. This group of patients must be kept under surveillance, not only for heart failure events but also for device-related issues. The reasons for higher complication rates in DCM patients require further evaluation.

A randomized double-blind crossover trial of triventricular versus biventricular pacing in heart failure.

AIMS: A significant proportion of patients implanted with biventricular (BiV) devices fail to respond. Clinical response may be improved by additional ventricular stimulation sites. This single-centre, double-blinded randomized crossover trial aimed to determine whether long-term multisite ventricular pacing is superior to conventional BiV pacing in heart failure patients. METHODS AND RESULTS: A total of 43 patients referred for cardiac resynchronization therapy (CRT) underwent transvenous implantation of a triventricular (TriV) device. Pacing leads were positioned in the right ventricular (RV) apex and a lateral coronary sinus (CS) branch, with a third ventricular lead implanted in a further lateral CS branch in 23 patients (group A) and on the high RV septum in 20 patients (group B). Devices were programmed in a randomized order to four pre-determined pacing configurations: conventional BiV, TriV, and dual-site and single-site left bentricular (LV) or RV pacing for 3-month periods with clinical and echo assessment at the end of each period. The primary endpoint was the comparison of 6 min walk distance (6MW) after 3 months of BiV vs. TriV pacing; secondary endpoints were Minnesota Living With Heart Failure (MLWHF) scores, and LV dimensions and function. The 12-month follow-up period was completed by 37 patients. Compared with BiV pacing, TriV pacing resulted in significant improvements in 6MW (451 ± 112 m vs. 425 ± 119 m, P = 0.008), MLWHF (32 ± 19 vs. 38 ± 24, P = 0.036), LV end-systolic volume (158 ± 79mL vs. 168 ± 76 mL, P < 0.05), and ejection fraction (30 ± 8% vs. 27 ± 8%, P < 0.05). CONCLUSIONS: TriV pacing was associated with significant improvements in clinical and echocardiographic parameters compared with BiV pacing.

Improving safety in the electrophysiology laboratory using a simple radiation dose reduction strategy: a study of 1007 radiofrequency ablation procedures.

BACKGROUND: The use of fluoroscopic screening involves exposure to ionising radiation for both patients and operators. OBJECTIVE: To assess the effects of radiation dose reduction manoeuvres (DRM) during radiofrequency ablation (RFA) procedures. DESIGN: Prospective study of DRM. SETTING: Tertiary cardiac centre. Interventions Two DRM were combined: removal of the secondary radiation grid and programming an ultra-low pulsed fluoroscopy rate. These methods were assessed using an anthropomorphic phantom model to measure skin entrance dose rates. Procedures were classified as complex (ablation of atrial fibrillation, ventricular tachycardia or complex congenital heart disease arrhythmias) or simple (all other RFA). MAIN OUTCOME MEASURES: Dose area product and screening times were compared for ablations performed before and after DRM. Equivalent doses to organs and malignancy risk were determined by computer modelling. RESULTS: Over a 39-month period, 1007 ablation procedures were performed (631 simple, 376 complex). Radiation dose was significantly reduced after DRM for both simple (20.4±26.9 Gycm(2) vs 8.0±10.3 Gycm(2), p<0.00001) and complex ablations (63.3±50.1 Gycm(2) vs 32.8±31.7 Gycm(2), p<0.00001) with no difference in screening times. The mean lifetime risk of fatal cancer attributable to radiation exposure per million procedures was reduced from 182 to 68 for simple ablations and from 440 to 155 for complex ablations. CONCLUSIONS: Significant reductions in radiation exposure during RFA were achieved using simple DRM, corresponding to a two-thirds reduction of the risk of excess fatal malignancy.

Biventricular device implantation in a patient with congenitally corrected transposition and left-sided superior vena cava.

An increasing number of patients with congenital heart disease are surviving into adulthood and some have indications for device therapy. Complex anatomical abnormalities may hinder the operator and require the adaptation of standard implantation techniques. We present the first report of successful biventricular ICD implantation in a patient with mesocardia, congenitally corrected transposition of the great arteries, pulmonary atresia, and a left superior vena cava draining into the coronary sinus. This case posed challenges in lead placement due to both complex anatomy and the risk of inappropriate device therapies secondary to far-field oversensing.